GAMP® 5

PE Magazine
IT Services: Applying Good IT Practice and Automation Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure...
Features
Cloud computing can be described as networked access and utilization of configurable computing resources such as data and information storage, processing capabilities, applications, and other services on computerized systems provided and/or maintained by a remote organization. As life sciences...
Features
In 2021, the ISPE GAMP® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient safety, product quality, and data integrity.
Features
Real-world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery.US Food and Drug Administration. “Use of Real-World Evidence to...
Video
Learning Level: Basic/Intermediate - Analytical laboratories are required to demonstrate the suitability of their equipment during audits and will typically follow USP requirements defined in Chapter <1058> on analytical...
Online Live
Online Live Overview This Virtual course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two-day fundamental course* introduces participants to regulatory requirements for computerized...
iSpeak Blog
Background As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting...
Features
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...
None
GAMP® refers to Good Automated Manufacturing Practice. A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users...